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New treatment option for Hip Fractures
Official title HIP Fracture Oral ThromboPROphylaxis (Hip PRO Pilot)
ClinicalTrials.gov ID: NCT05775965
What this study is testing
What is Rivaroxaban 10mg?
Rivaroxaban 10mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hip fractures.
Also referred to as Rivaroxaban.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- As our Canadian population ages, hip fractures in these older adults are becoming very common. The best treatment for the majority of these injuries is urgent treatment with surgery.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Patients aged 50 years or older with an acute hip fracture (presentation to hospital within 24 hours of injury) that requires surgical treatment will...
- Age ≥ 50 years with a hip fracture (AO-OTA classification 31-A1-A3 and 31-B1-B3) amenable to surgical treatment (presentation to hospital within 24...
- Both open and closed fractures will be included, and open fractures will be documented.
- Patients on single agent anti-platelet therapy (i.e., acetylsalicylic acid or clopidogrel) will be included.
- Signed informed consent or surrogate consent to participate in study.
You likely can't join if
- Delayed presentation (over 24 hours between hip fracture and presentation to hospital).
- Pathological fractures secondary to primary cancer or metastatic bone disease.
- Peri-prosthetic femur fractures.
- Received more than two doses of any thromboprophylaxis agent post-operatively, prior to randomization.
- Pre-hospital therapeutic intensity antithrombotic therapy, including LMWH, Warfarin, DOACs, clopidogrel/ticagrelor, or chronic ASA use of any dose in...
- Known inherited bleeding or clotting disorder (factor V Leiden gene mutation, prothrombin gene mutation, protein C or protein S deficiency...
See the full eligibility criteria
- Patients aged 50 years or older with an acute hip fracture (presentation to hospital within 24 hours of injury) that requires surgical treatment will be approached for inclusion in the study:
- Age ≥ 50 years with a hip fracture (AO-OTA classification 31-A1-A3 and 31-B1-B3) amenable to surgical treatment (presentation to hospital within 24 hours of injury). Patients with additional injuries will be included...
- Both open and closed fractures will be included, and open fractures will be documented.
- Patients on single agent anti-platelet therapy (i.e., acetylsalicylic acid or clopidogrel) will be included.
- Signed informed consent or surrogate consent to participate in study.
- Delayed presentation (over 24 hours between hip fracture and presentation to hospital).
- Pathological fractures secondary to primary cancer or metastatic bone disease.
- Peri-prosthetic femur fractures.
- Received more than two doses of any thromboprophylaxis agent post-operatively, prior to randomization.
- Pre-hospital therapeutic intensity antithrombotic therapy, including LMWH, Warfarin, DOACs, clopidogrel/ticagrelor, or chronic ASA use of any dose in the three months prior to hip fracture.
- Known inherited bleeding or clotting disorder (factor V Leiden gene mutation, prothrombin gene mutation, protein C or protein S deficiency, antithrombin deficiency).
- Intracranial hemorrhage requiring serial CT scans of the brain and/or surgical intervention.
- Contraindication to ASA use (allergy, documented gastrointestinal ulcer within the past year, severe thrombocytopenia [platelet count \<50 x109/L at the time of hospital admission]).
- Contraindication to rivaroxaban use (allergy, acute renal failure [CrCl \<30 mL/min]).
- Participant or surrogate unable to or unwilling to provide consent or complete follow-up. Or surrogate consent not available.
- Under age 50 years (more likely high energy, multiple injuries).
- Multiply injured patients who require prolonged thromboprophylaxis or delayed thromboprophylaxis initiation.
- Patient unable to attend follow-up visits.
- Currently incarcerated, at a correctional facility.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- New Westminster, British Colombia, Canada
- Ottawa, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; New Westminster, British Colombia, Canada; Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.